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Provera Consumer Information

PROVERA

Generic Name: medroxyprogesterone (me DROX ee proe JESS te rone)

Brand Names: Amen, Curretab, Cycrin, Provera

What is the most important information I should know about medroxyprogesterone?

• Do not take medroxyprogesterone if you are pregnant or planning to become pregnant. It could affect the development of your baby.

What is medroxyprogesterone?

• Medroxyprogesterone is a female hormone, usually called "progesterone". It is important for the regulation of ovulation and menstruation.
• Medroxyprogesterone is used to treat conditions such as irregular or abnormal uterine bleeding and lack of menstruation.
• Progesterone or progesterone-like drugs have been used to prevent miscarriage in the first few months of pregnancy. No adequate evidence is available to show that they are effective for this purpose. Furthermore, most cases of early miscarriage are due to causes which could not be helped by these drugs.
• These drugs have been used as a test for pregnancy but such use is not longer considered safe because of possible damage to a developing baby. Also, more rapid methods for testing for pregnancy are now available.
• Medroxyprogesterone may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking medroxyprogesterone?

• Do not take medroxyprogesterone without the approval of your doctor if you have
• a bleeding or blood-clotting disorder,
• any type of breast or uterine cancer, or
• liver or gallbladder disease.
• Before taking this medication, tell your doctor if you have
• epilepsy or a seizure disorder,
• migraines,
• asthma,
• kidney disease,
• heart disease, or
• diabetes.
• You may not be able to take medroxyprogesterone, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.
• Medroxyprogesterone is in the FDA pregnancy category D. This means that medroxyprogesterone is known to harm an unborn baby. There is an increased risk of minor birth defects in children whose mothers take this drug during the first 4 months of pregnancy. Several reports suggest an association between mothers who take these drugs in the first trimester of pregnancy and genital abnormalities in male and female babies. The risk to the male baby is the possibility of being born with a condition in which the opening of the penis is on the underside rather than the tip of the penis (hypospadias). Hypospadias occurs in about 5 to 8 per 1000 male births and about doubled with exposure to these drugs. There is not enough information to quantify the risk to exposed female fetuses, but enlargement of the clitoris and fusion of the labia may occur, although rarely.
• Therefore, since drugs of this type may induce mild masculinization of the external genitalia of the female fetus, as well as hypospadias in the male fetus, it is wise to avoid using the drug during the first trimester of pregnancy. Do not take this medication if you are pregnant or if you are planning a pregnancy.
• Detectable amounts of medroxyprogesterone enter the milk of mothers receiving medroxyprogesterone. The effect on the nursing infant has not been determined. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take medroxyprogesterone?

• Take medroxyprogesterone exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take each dose with a full glass of water.
• Take medroxyprogesterone with food or milk to lessen stomach upset.
• Try to take your doses at the same time each day. Medroxyprogesterone is usually taken for a certain number of days each month according to your body's natural cycle.
• Store medroxyprogesterone at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed dose as soon as you remember. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

• A medroxyprogesterone overdose is unlikely to threaten life. Call an emergency room or poison control left for advice.
• Symptoms of a medroxyprogesterone overdose include nausea, vomiting, fluid retention (swelling of the hands and feet), breast discomfort, and vaginal bleeding.

What should I avoid while taking medroxyprogesterone?

• Avoid smoking while taking medroxyprogesterone. Smoking greatly increases the risk of blood clot formation.
• Avoid excessive salt intake. Too much salt may cause fluid retention and discomfort.
• Avoid prolonged exposure to sunlight. Medroxyprogesterone may increase the sensitivity of your skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.

What are the possible side effects of medroxyprogesterone?

• Stop taking medroxyprogesterone and seek emergency medical attention or call your doctor immediately if you experience any of the following serious side effects:
• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
• shortness of breath or pain in your chest;
• a sudden severe headache;
• visual changes;
• a painful, red, swollen leg;
• numbness or tingling in an arm or leg;
• prolonged, heavy, vaginal bleeding;
• stomach or side pain; or
• yellowing of your skin or eyes.
• Other, less serious side effects may be more likely to occur. Continue to take medroxyprogesterone and talk to your doctor if you experience
• changes in appetite or weight,
• swelling of your hands or feet,
• changes in your menstrual cycle,
• depression,
• acne,
• an increase in body or facial hair or hair loss,
• tenderness of the breasts,
• nausea,
• headache or insomnia,
• changes in your voice, or
• areas of darker skin.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect medroxyprogesterone?

• Before taking medroxyprogesterone, tell your doctor if you are taking any of the following medications:
• insulin or an oral diabetes medicine such as glipizide (Glucotrol), glyburide (Diabeta, Micronase, Glynase), chlorpropamide (Diabinese), tolazamide (Tolinase), and tolbutamide (Orinase);
• bromocriptine (Parlodel);
• aminoglutethimide (Cytadren);
• phenobarbital (Solfoton, Luminal); or
• chlorpromazine (Thorazine), fluphenazine (Prolixin), mesoridazine (Serentil), perphenazine (Trilafon), prochlorperazine (Compazine), promazine (Sparine), thioridazine (Mellaril), or trifluoperazine (Stelazine).
• You may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.
• Drugs other than those listed here may also interact with medroxyprogesterone. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

• Your pharmacist has additional information about medroxyprogesterone written for health professionals that you may read.
• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Limitations of This Information

Efforts have been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information does not endorse drugs, diagnose patients or recommend therapy. This is an educational resource only intended to supplement but not to replace the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, please check with your doctor, nurse or local pharmacist. This site does not assume any responsibility for any aspect of healthcare administered with the aid of information provided here.

Full public license and copyright information is available separately from Cerner Multum, Inc.

Version: 3.04. Revision Date: 2/14/03.